MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
FDA Recall Z-0731-2017 · Posted None
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-12-02
Date Terminated2021-11-05
Product Quantity47
Reason for Recall
Edits to Particle field definition parameters may not be saved when the field definition window is saved.
Firm Action
The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter dated 11/2016 was sent to affected customers on 12/2/2016. The letter describes the product, problem and actions to be taken. The customers were instructed to save and re-open the field definition form when manual edits have been performed to confirm that the edits were save; post this notice in a place accessible to all users; advise the appropriate personnel working with the product the content of the letter; and complete and return the Acknowledgement Form via fax to: 408 830 8003 immediately upon receipt but no later than 30 days.
Elekta will resolve the problem with the MOSAIQ 2.60 SP7F, MOSAIQ 2.60 SP14 and 2.64 SP3. Customers are encouraged to contact Elekta support to get the corrected version.
If you have any questions, contact RA Manager Americas at 1-770-300-9725 or email to: [email protected].
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of: Italy, Japan, South Korea, Sweden and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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